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Abstract Details

Number Needed to Treat to Prevent Relapse and Disability Worsening Among Patients with Relapsing MS Treated with Teriflunomide or Cladribine
Multiple Sclerosis
P3 - Poster Session 3 (5:30 PM-6:30 PM)
15-074

To report results of a comparative number needed to treat (NNT) analysis of teriflunomide and cladribine.

Teriflunomide is an oral immunomodulator approved for the treatment of relapsing forms of multiple sclerosis (MS). The recent approval of cladribine for highly active relapsing MS provides another oral MS treatment option. No head-to-head trials of teriflunomide and cladribine have been conducted. NNT analysis may be used to indirectly evaluate comparative efficacy of these treatments.

NNTs were derived from 2-year core study data from the Phase 3 CLARITY (NCT00213135) trial (cumulative dose of cladribine 3.5 mg per kilogram of bodyweight over 96 weeks) and the Phase 3 TEMSO (NCT00134563) and TOWER (NCT00751881) studies of once-daily teriflunomide 14 mg. NNTs to prevent 1 relapse (based on number of relapses [event rates]) or 1 patient experiencing 12-week confirmed disability worsening (12wCDW) are presented.

Over 2 years, risk of relapse and proportions of patients with 12wCDW were significantly reduced with both teriflunomide and cladribine versus placebo. The NNT to prevent 1 event rate-based relapse was comparable for teriflunomide in TEMSO (5.9) and TOWER (5.2) versus cladribine in CLARITY (5.3). NNTs to prevent 12wCDW at Year 2 were comparable for teriflunomide in TEMSO (15.6) and TOWER (14.9) versus cladribine in CLARITY (15.9).

Using 2-year core study clinical data, this NNT analysis demonstrates a comparable effect of teriflunomide and cladribine on event rate-based relapses and 12wCDW. These results reinforce the established clinical efficacy of teriflunomide 14 mg for the treatment of relapsing MS and may help to further inform treatment decisions in daily clinical practice.
Authors/Disclosures
Aaron L. Boster, MD (Ohiohealth)
PRESENTER 		Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for sanofi. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for roche. Dr. Boster has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for novartis. Dr. Boster has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medtronic. Dr. Boster has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Serono. The institution of Dr. Boster has received research support from Sanofi. The institution of Dr. Boster has received research support from Roche.
Regina Berkovich, MD, PhD (Regina Berkovich MD PhD Inc) The institution of Dr. Berkovich has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Alexion, Biogen, Genentec, Mallincrodt, Sanofi, Novartis, . Dr. Berkovich has received personal compensation in the range of $10,000-$49,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen, Genentec, Sanofi, Merck . Dr. Berkovich has received personal compensation in the range of $50,000-$99,999 for serving on a Speakers Bureau for Alexion, Biogen, Sanofi, Merck, Mallincrodt . The institution of Dr. Berkovich has received research support from Biogen, Sanofi, Merck.
Daniel Kantor, MD, FAAN (Medical Partnership 4 MS+) Dr. Kantor has received personal compensation for serving as an employee of Gateway Institute for Brain Research. Dr. Kantor has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Bristol Myers Squibb. Dr. Kantor has a non-compensated relationship as a HAP with MSFous (MSF) that is relevant to AAN interests or activities. Dr. Kantor has a non-compensated relationship as a Medical Board with MS Views & News that is relevant to AAN interests or activities.
Elizabeth Poole No disclosure on file
Nora Roesch No disclosure on file
Jeffrey M. Chavin, MD, FAAN (Sanofi) Dr. Chavin has received personal compensation for serving as an employee of Sanofi. Dr. Chavin has stock in Sanofi.
No disclosure on file
Aaron E. Miller, MD, FAAN (Mt Sinai School Of Med) Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Accordant Health Services (Caremark). Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Corevitas (formerly known as Corrona). Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for MAPI=Pharma. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Viatris (Mylan). Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Guidepoint Global. Dr. Miller has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Gerson Lehrman Group. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Biogen Idec. Dr. Miller has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Dr. Miller has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen (Horizon Therapeutics). Dr. Miller has received personal compensation in the range of $50,000-$99,999 for serving as an Expert Witness for Sterne Kessler. Dr. Miller has received publishing royalties from a publication relating to health care.